Clinical Research Associate II

Clinical, Medical Services & Regulatory Affairs Maple Grove, Minnesota


Description

Do you thrive in a fast paced environment? Do you have the passion and drive to manage multiple clinical study sites? Can you connect the dots with your critical thinking skills?

If your answer is yes, then we may be looking for you!

Spectranetics
, recently named one of the “Most Trusted Companies”, has an opening for a Clinical Research Associate II.

What You Will Do: You will work with our Clinical Project Manager to meet applicable regulatory standards and company requirements for Global Clinical Studies. You will support study management activities, general site management and oversight of CRO, and need to have expertise in GCP, EU regulatory environment as well as interfacing with multiple functional groups: Clinical Field Specialists, Marketing, Sales, Regulatory, Quality, Data Management, Finance/Accounts Payable.

What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from your fellow Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.

What You Will Become: A highly influential driver who will be key in supporting clinical research studies for high impact results helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.

What Success Looks Like:

  • Assists with successful conduct of assigned studies consistent with the Clinical Strategy. This includes interfacing with representatives from key functional groups including Field Monitoring, Quality Affairs, Product Development, Manufacturing, Sales, Marketing, Customer Service, Regulatory Affairs, R&D, and European Clinical Groups
  • Assists in preparation of study related material and training materials
  • Assists with training of investigators, center staff and Spectranetics staff
  • Works with Clinical Research Manager to develop plan to ensure device accountability for clinical sites
  • Assists Clinical Field Specialists and Clinical Research Manager in obtaining all necessary documents from clinical sites prior to site initiation and updating documents as determined by needs and length of trial
  • Reviews and verifies adequacy of center activation documentation
  • Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipts of accurate data and other required study documents
  • Reviews monitoring reports and identifies discrepancies in reports and study files and ensures correction activities are completed
  • Reviews clinical data/information and oversees data correction
  • Assists Clinical Research Specialists in providing interim and final reports and presentations
  • Provides input to study budgets and project plans
  • Works with the Clinical Research Manager to oversee the organization of the Master File and Site files for Clinical Trials
  • Assists with second and third pass data entry as needed
  • Performs Site Qualification, Monitoring, and/or Close-out visits as requested
  • Performs audits of sponsor monitoring, sites files, CROs
  • Assists Clinical Research Manager by providing sections of Investigational Plan or protocol as needed
  • Assists Clinical Research Manager in writing sections of PMA Clinical Reports
  • Takes initiative to oversee activities of Contract Research Organizations (CRO)
  • Assists in the preparation of materials for CEC and DSMB meetings
  • Assists in support of data validation and database closure as directed
  • Acquire professional, product and market expertise via independent reading, networking, and training
  • Comply with applicable FDA and international regulatory laws/standards, company-wide and departmental Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs)
  • Perform related duties as assigned

Required Knowledge and Skills:

  • Ability to work independently and as part of a team
  • High attention to detail and accuracy
  • Advanced written and oral communications skills
  • Able to manage multiple tasks
  • Proficient knowledge of medical terminology
  • Expertise with GCP and regulatory compliance guidelines for clinical trials
  • Good problem-solving skills
  • Knowledge of clinical and outcomes research study design

Qualifications:

  • Bachelor’s degree (technical or non-technical), i.e. engineering biological sciences or related medical/scientific field, Master’s degree may substitute for 1 year experience
  • minimum of 2-3 years’ experience as a CRA or similar experience in a medical/scientific area is required, preferably in Medical Device clinical studies.  Six or more years’ experience may substitute for Bachelor’s degree.
  • Clinical Site Trial experience preferred – site qualification, training on GCP, investigator, protocol and CRF training

Special Requirements:

  • High standard of integrity
  • Position may require up to 30% travel
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter.  All resumes must be submitted to the vendor portal under these terms or they will not be considered.

This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.

All applicants must pass a pre-employment drug screen to be hired.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status or status as an individual with a disability.